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Money, Time, Effort, Errors: How Much Is Paper Costing You?

Remaining on paper — whether for processes, documentation, authorizations, resource management, or other purposes — is highly inefficient for pharma manufacturing. In this article, we’ll explore the true costs of paper in resources, time, and accuracy.

September 22, 2022

Industry Perspective

Although COVID and the shift to remote work has accelerated digital tech adoption in pharma, many manufacturers are still hesitant to take on the burden of converting from paper.

And for good reason. Transitioning processes, documentation, and resources is a time-consuming process that requires staff to be retrained and onboarded with digital solutions.

However, making the migration is easier than you think and the long-term gains are undeniable. Manufacturing companies that embrace digital solutions save time, money, and effort.

In this article, we’ll explore the true cost of paper for pharma manufacturing and explain why digital transformation for pharma companies is here to stay.

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The True Cost of Paper: 4 Types of Resource Burdens

Paper is a tried and tested method for capturing and sharing data, but the costs can be astronomical. Read on for four of the top hidden costs of paper for pharmaceutical manufacturers:

#1: Paper Costs Money; Digital Solutions Save Money

Although paper is widely available and easy to source, it isn’t easy to sift through or maintain. It can take weeks or months to organize and review procedures and batches for regulatory compliance.

Plus, it’s expensive. Time spent processing paper documents costs companies $19.7k per worker, per year. For big pharma manufacturing companies, this can easily amount to hundreds of thousands of dollars annually.

Mic drop. 🎤

Fortunately, you don’t have to burn your dollars — you can save them. Digital solutions built for pharma manufacturing provide your team with real-time visibility into drug production. As a result, they can easily monitor data and ensure issues are addressed in a timely manner, thereby saving you money. This is true regardless of whether production happens in-house or is handled externally by a contracted partner.

“It is easy to overlook the cost of managing a paper-based solution. Retrieving and analyzing batch records can be costly with a paper-based system, especially if the paper records are not easily retrievable.”

Eileen Sullivan-Scully, Senior Sales Executive, Apprentice

#2: Paper Consumes Time; Digital Solutions Save Time

Reviewing procedures and batches for regulatory compliance isn’t exactly anyone’s idea of a good time. This process is time-consuming, often taking months to complete. It requires personnel to dive into lengthy paper trails and verify that each step was followed correctly and that all necessary authorizations were given.

Furthermore, manual transcription can be a serious time suck! The annual cost of maintaining paper records amounts to almost a quarter of the workforce. In fact, 213 out of every 1,000 employees (21.3% of time per worker) gets bogged down by manual transcription. 

However, digital solutions are changing this narrative. With modern tech, pharmaceutical manufacturers can record and store all of the documentation needed for regulatory bodies to audit and approve a batch release, all within one central location.

#3: Paper Takes Effort; Digital Solutions Save Resources

Tech transfers are vital to progressing operations, but they can be cumbersome when based on paper.

Paper documentation may be incomplete or unavailable, and verbal information can be miscommunicated or misunderstood. And when multiple disparate point solutions are used by an organization, there is an increasing number of tech transfers that are needed, as well as complexity to match.

Enter digital solutions. Modern tech allows pharma companies to share information instantly across teams and sites. This simplifies production and tech transfer, and ensures all stakeholders have access to the right information at the right time.

“To remain competitive, it is critical for pharma companies to address their workforce skill gaps by ensuring that their employees have the skills required to operate and benefit from digital technologies and increased automation.”

Hillary Dukart, Consultant, McKinsey

#4: Paper Is Prone to Errors; Digital Solutions Ensure Accuracy

One of the biggest drawbacks of exclusively using paper-based records is that they’re prone to human error.

Depending on the location and personnel, data capture and transcription formats may vary. This can create issues down the line when tech transfers, batch production, or other processes are initiated.

Common human errors related to pharmaceutical production include:

And we don’t mean to be debbie downers, but missing or misinterpreting data has consequences that will lead to a Form 483 when it comes time for an audit.

Additionally, with paper-only records there’s a lack of backup data. This means important information can be lost without a trace, which can have detrimental consequences when it comes to passing regulatory audits. Furthermore, the storage of paper records is unscalable — more paper, more problems.

Digital solutions for pharma companies solve these issues by:

  • Automating data capture and transcription
  • Maintaining digital records 
  • Managing resources such as equipment, labor, and inventory
  • Ensuring compliance with regulatory agencies 

Translation? Digital solutions for pharma reduce the likelihood of errors, saving ample time and resources every step of the way.

“Paper based systems can cause a number of different discrepancies. These discrepancies can all be reduced by moving to an electronic system, which minimizes data entry errors and missing data to prevent these incorrect entries.”

Eileen Sullivan-Scully, Senior Sales Executive, Apprentice

Change Management to Digital: It’s Worth It

Nobody likes change, and the lift from paper to digital systems can seem daunting. But as we’ve seen, the costs of remaining on paper are too high to justify the “if it ain’t broke, don’t fix it” mentality. 

To ensure a successful change management to digital, look for ways to proactively acknowledge and resolve these concerns within your company.

And remember — finding a good solution is only half the battle. You'll need to make sure your employees understand the reason behind the change, and the value it provides.

To accomplish this, follow the 3 Cs of change management to ensure your communications are:

  1. Clear
  2. Compelling
  3. Credible
“The resistance to paper in the pharmaceutical space is understandable. You’re comfortable with this paper-based solution, the answers are all there, it’s been tested and tried.”

Lisa Young, Sr. Instructional Designer, Apprentice

Closing Thoughts: Go Digital & Save — Big Time

Like it or not, digital transformation for pharma companies is here to stay. Manufacturers that don’t adopt modern solutions risk being left behind.

Fortunately, transitioning from paper-based records to digital solutions is easier than you think. And the best part? You can work with your paper solutions, rather than against them.

“In 12 months’ time, Apprentice helped us free up 9,000 hours from manual transcription.”

Apprentice customer

Our Tempo platform is built specifically for pharma manufacturers, with validation and compliance front and center. Drop us a line and we’ll help you go digital so you can save your valuable time, money, and resources and get back to doing what you do best: getting life-saving drugs to the people who need them, faster.

Our Featured Thought Leader

Eileen’s Background

Eileen Sullivan-Scully started her career in pharma, where she worked with oncology and hematology patients participating in clinical trials. She saw first hand the difficulties these people faced, and how hard they fought to stay alive; many died waiting for new therapeutics to become available.

Eileen’s primary life objective is to help others, which is why Eileen uses her scientific background to connect with life science companies and demonstrate how Apprentice’s cutting-edge technology streamlines drug development and manufacturing. 

From planning batches with greater precision and speed to monitoring data, performing investigations, and assessing performance, Eileen takes complicated information and breaks it into easy-to-grasp, simplified insights.

Want to find out more about Eileen? Read her Spotlight on our company blog to find out more about her work background (and see some adorable pictures of her puppies, Rocky and Bella).

MEET EILEEN

Cost of Paper: Eileen’s Point of View

“Electronic solutions allow for easy retrieval of data to assist with investigations, inspections, and audits. Enabling Review by Exception helps reduce the examination time spent by the QA organization by reviewing only batch records that contain exceptions generated during batch execution. Batch records without exceptions get verified by the system and better yet, they require minimum QA review.”

References

  1. DataIntegrity | FDA. (2018, December). Food and Drug Administration. https://www.fda.gov/media/119267
  2. Dukart, H., Patel, P., Telpis, V., & Yngve, J. (2021, September 15). Pharma operations: Creating the workforce of the future. McKinsey & Company. Retrieved September 15, 2022, from https://www.mckinsey.com/industries/life-sciences/our-insights/pharma-operations-creating-the-workforce-of-the-future
  3. Edwards, D. 5 Reasons Paper Has No Place in Contract Manufacturing. (2021, March 1). Contract Pharma. Retrieved September 15, 2022, from https://www.contractpharma.com/issues/2021-03-01/view_features/5-reasons-paper-has-no-place-in-contract-manufacturing/
  4. GovInfo. (2011). GovInfo. https://www.govinfo.gov/app/details/CFR-2011-title21-vol4/CFR-2011-title21-vol4-sec211-103
  5. Office of Regulatory Affairs. (2020, January 9). FDA Form 483 Frequently Asked Questions. U.S. Food and Drug Administration. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions